New hope for Hard-to-Treat leukemia: targeted pill combined with chemotherapy enters human trials

NCT ID NCT06226571

Ongoing Disease control Sponsor: Syndax Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new oral drug called SNDX-5613 alongside standard intensive chemotherapy in people newly diagnosed with acute myeloid leukemia (AML) that has specific genetic changes (KMT2A, NPM1, or NUP98). The study aims to see if the combination is safe and tolerable, and how well it works. About 76 participants will receive the drug during induction, consolidation, and maintenance phases of treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

SNDX-5613 (a targeted cancer pill) combined with standard chemotherapy drugs (cytarabine, daunorubicin or idarubicin)

What this could lead to

If successful, this could lead to a new treatment option for certain genetic types of AML that are hard to treat.

What could go wrong

This is an early Phase 1 trial with only 76 people, so safety and effectiveness are not yet proven. Side effects from the drug combination are unknown.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKEMIAS

Contacts and locations

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Locations

AdventHealth Blood & Marrow Transplant Center

Orlando, Florida, 32804, United States
Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States
Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States
Baylor University Medical Center

Dallas, Texas, 75246, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
City of Hope

Goodyear, Arizona, 85338, United States
City of Hope Medical Center

Duarte, California, 91010, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
East Carolina University

Greenville, North Carolina, 27834, United States
Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Gordon and Leslie Diamond Health Care Center

Vancouver, British Columbia, V5Z 1M9, Canada
Hammersmith Hospital

London, London, City of, W12 0HS, United Kingdom
Hospital Clinic de Barcelona

Barcelona, 8036, Spain
Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain
Hospital San Pedro de Alcantara

Cáceres, 10003, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario De Salamanca

Salamanca, 37007, Spain
Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain
Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain
Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain
Institution name: Northwell Health-Brany

Lake Success, New York, 11042, United States
LDS Hospital - Intermountain Healthcare

Salt Lake City, Utah, 84143, United States
MUSC Hollings Cancer Center (HCC)

Charleston, South Carolina, 29425, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Northern Hospital, Victoria

Epping, Victoria, 3076, Australia
Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, 40207, United States
Oregon Health and Science University- Center for Hematologic Malignancies

Portland, Oregon, 97239, United States
Royal Adelaide Hospital

Adelaide, SA 5000, Australia
Royal Perth Hospital

Perth, Western Australia, 6000, Australia
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Sir Charles Gairdner Hospital

Nedlands, 6009, Australia
Tampa General Hospital

Tampa, Florida, 33606, United States
The Alfred Hospital, Victoria

Melbourne, 3004, Australia
The Royal Marsden NHS

Sutton, SM2 5PT, United Kingdom
The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States
UCLA Medical Hematology

Burbank, California, 91505, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
Universitat de Valencia

Valencia, 46026, Spain
University Medical Center Utrecht

Utrecht, 3584, Netherlands
University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada
University of Chicago

Chicago, Illinois, 60637, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Louisville Health Brown Cancer Center

Louisville, Kentucky, 40202, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Virginia University

Morgantown, West Virginia, 26506, United States